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PrProfile: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Feb 2027 → Apr 2027
See other at-risk trials from Ionis Pharmaceuticals

Record History

  1. Primary completion pushed from Feb 2027 to Apr 2027 Completion pushed from Jun 2030 to Aug 2030 · Study description shortened, about 7 words Show 2 more changesShow less
    • Completion pushed from Jun 2030 to Aug 2030
    • Study description shortened, about 7 words
  2. Primary completion date: Feb 2027 to Apr 2027 Completion date: Jun 2030 to Aug 2030 · Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 1 of 6 entries Show 3 more changesShow less
    • Completion date: Jun 2030 to Aug 2030
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 6 entries
  3. Study description shortened, about 13 wordsv32 See this version in full on ClinicalTrials.gov ↗
  4. Enrollment closed, study ongoing Enrollment increased: 76 → 85 participants · Site details revised at 13 of 13 sitesv31 Show 2 more changesShow less
    • Enrollment increased: 76 → 85 participants
    • Site details revised at 13 of 13 sites
  5. Site details revised at 2 of 13 sitesv30
Show 28 earlier versionsHide 28 earlier versions
  1. Site details revised at 1 of 13 sitesv29
  2. Site details revised at 3 of 13 sitesv28
  3. Site details revised at 1 of 13 sitesv27
  4. Site details revised at 1 of 13 sitesv26
  5. Site details revised at 1 of 13 sitesv25
  6. Site details revised at 1 of 13 sitesv24
  7. 2 versions Re-verified, no change to tracked fieldsv22-v23
  8. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Jul 2025 to Feb 2027 · Enrollment target: 56 to 76 · Study sites: 16 to 13 · 3 morev21 Show 6 more changesShow less
    • Primary completion date: Jul 2025 to Feb 2027
    • Enrollment target: 56 to 76
    • Study sites: 16 to 13
    • Completion date: Jul 2027 to Jun 2030
    • Study description expanded, about 25 words
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  9. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Mar 2025 to Jul 2025 · Completion date: Jun 2027 to Jul 2027 · Site details revised at 16 of 16 sitesv20 Show 3 more changesShow less
    • Primary completion date: Mar 2025 to Jul 2025
    • Completion date: Jun 2027 to Jul 2027
    • Site details revised at 16 of 16 sites
  10. Study title revisedv19 See this version in full on ClinicalTrials.gov ↗
  11. Completion date: Oct 2025 to Jun 2027 Secondary endpoints: details revised at 2 of 6 entries · Study description expanded, about 22 wordsv18 Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description expanded, about 22 words

    See this version in full on ClinicalTrials.gov ↗

  12. Trial status: Active, Not Recruiting to Recruiting Study description shortened, about 37 words · Site details revised at 16 of 16 sitesv17 Show 2 more changesShow less
    • Study description shortened, about 37 words
    • Site details revised at 16 of 16 sites

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 14 to 16v16
  14. Study sites: 13 to 14v15
  15. Study sites: 11 to 13v14
  16. Re-verified, no change to tracked fieldsv13
  17. Trial status: Recruiting to Active, Not Recruiting Study description expanded, about 37 words · Site details revised at 11 of 11 sites · Study title expanded, about 1 wordv12 Show 3 more changesShow less
    • Study description expanded, about 37 words
    • Site details revised at 11 of 11 sites
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  18. Re-verified, no change to tracked fieldsv11
  19. Study sites: 9 to 11v10
  20. Study sites: 7 to 9v9
  21. Study sites: 6 to 7v8
  22. Study sites: 5 to 6 Start date changed from estimate of Jan 2024 to Jan 4, 2024v7 Show 1 more changeShow less
    • Start date changed from estimate of Jan 2024 to Jan 4, 2024
  23. Study sites: 4 to 5v6
  24. Study sites: 3 to 4v5
  25. Study sites: 2 to 3v4
  26. Study sites: 1 to 2 Start date: Dec 2023 to Jan 2024v3 Show 1 more changeShow less
    • Start date: Dec 2023 to Jan 2024
  27. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intrathecal (IT) delivery of ION717.
Trial Details
NCT Number NCT06153966
Lead Sponsor Ionis Pharmaceuticals, Inc.
Conditions Prion Disease
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov